C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical review of the following therapeutic classes/drugs:

Public comments:

Growth Hormones:

The Committee was asked to consider information regarding clinical trial results including pediatric and adult indications, safety, efficacy, side effects, product formulations, and dosing. The Committee was also asked to consider drug delivery devices, patient support programs, and storage requirements.

Xyrem (sodium oxybate)

The Committee was asked to consider information regarding clinical trial results including product indications and efficacy, as well as post-marketing data regarding abuse potential and potential for dependence, and the Xyrem Success Program. The presenter also noted the practice parameters of the American Academy of Sleep Medicine.

Alzheimer's Agents:

The Committee was asked to consider information regarding clinical trial results including indications, mechanism of action, pharmacokinetics, efficacy and effectiveness in different stages of Alzheimer's Disease and Parkinson's Disease, safety, tolerability, dosage, adverse events, frequency of dosing, and combination therapy with an acetylcholinesterase inhibitor and an NMDA inhibitor.

Multiple Sclerosis Agents:

The Committee was asked to consider information regarding clinical trial results including indications, mechanism of action, dosing frequency, dosage forms, tolerability, safety, use with a first clinical episode, and efficacy in long term studies.

Pegylated Interferons:

The Committee was asked to consider clinical information regarding indications, efficacy, safety and tolerability in a broad range of patients with hepatitis C virus, predictability and durability of response, approval for retreatment and use in the pediatric population, and weight based versus fixed dosing.

Inhaled Beta-2 Adrenergic Agents - Short Acting:

The Committee was asked to consider information regarding dose counters, shelf life and product stability, and the importance of reliable, consistent albuterol availability when needed.

Thiazolidinediones:

The Committee was asked to consider information regarding clinical trial results including efficacy and safety as monotherapy and as add-on therapy, and the results of the ADOPT, DREAM, RECORD and BARI-2D trials.

Pharmacy and Therapeutics Committee Comments:

Several Committee members asked for clarification regarding needle-free versus non-needle-free devices for several of the growth hormone products.

A Committee member asked about New York specific data for sodium oxybate with regard to diversion. Another member commented on off label use of the drug, and a member asked about the product registry and whether they documented off-label use.

A Committee member asked for clarification regarding peginterferon alfa-2b and peginterferon alfa-2a with regard to the approved ages for dosing in each product's labeling.

A Committee member and presenter discussed the TZD class on a cellular level with regard to the positive effects of the drugs on insulin resistance, insulin sensitivity and glucose transport versus the negative effects on lipid profiles, and also the mechanisms of the weight gain that tends to occur with the drugs in this class.

D. Clinical Presentation and Discussion

Barbara Rogler, PharmD, MS, First Health Services Corporation; Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP); Holly Coe, PharmD, School of Pharmacy & Pharmaceutical Sciences, State University of New York at Buffalo; Fred Doloresco, PharmD, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo; Linda Catanzaro, PharmD, School of Pharmacy & Pharmaceutical Sciences , State University of New York at Buffalo; Leigh Briscoe-Dwyer, Pharm.D., BCPS, CGP
NorthShore - LIJ Health System, NYS Medicaid DUR Board Co-Chairperson

Inclusion of the Growth Hormones therapeutic class in the Clinical Drug Review Program (CDRP)

The Committee was asked to consider a proposal to include the Growth Hormones therapeutic class in the Clinical Drug Review Program. As presented, the products within the Growth Hormone therapeutic class would require prior authorization in order to evaluate and address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health and potential for overuse or misuse.

Dr. Coe presented the Committee with a review of human growth hormone in regard to public health concerns with cancer and increased risks of diabetes, abuse and illicit use, and use for non-FDA approved indications. She also provided information on prior authorization requirements from comparator state Medicaid programs. Dr. Doloresco presented data specific to the NY Medicaid program and focused on utilization outside of the FDA approved indications. Dr. Coe concluded that adding the growth hormones therapeutic class to the CDRP would promote appropriate prescribing, improve awareness of abuse potential, and raise awareness of potential diabetes and cancer concerns.

Dr. Briscoe-Dwyer noted that the Growth Hormone therapeutic class was reviewed during the July 2, 2009 DUR Board Meeting. The DUR Board agreed that human growth hormone met the criteria for inclusion into the CDRP, and recommended that the Medicaid P&T Committee consider HGH for inclusion into the CDRP and require prior authorization for patients over 21 years of age.

The Committee and presenters discussed Serostim, which is currently managed in the CDRP, the NY Medicaid data with regard to appropriate utilization in adult and pediatric patients, the potential age at which a prior authorization may be required and the need to inquire about closed epiphyses during the prior authorization process if only adult patients need authorization.

After further discussion and considering the information and concerns raised by interested parties and the membership, the Committee agreed that the human growth hormone therapeutic class meets the criteria for inclusion into the CDRP and voted unanimously to recommend that it be included in the CDRP and prior authorization be required for patients 21 years of age or older.

Inclusion of tadalafil (Adcirca) in the Clinical Drug Review Program (CDRP)

The Committee was asked to consider a proposal to include tadalafil (Adcirca) in the Clinical Drug Review Program. As presented, the drug would require prior authorization in order to evaluate and address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health and potential for overuse or misuse.

Dr. Rogler provided background information on Pulmonary Arterial Hypertension (PAH) including major pathways associated with the disease and the current treatment strategies. She then provided background information for tadalafil, including indications, dosage, contraindications, warnings and precautions, pharmacokinetics, drug interactions, and use in special populations.

Dr. Correia presented the information related to the phosphodiesterase type-5 (PDE5) drug class, noting that tadalafil is a PDE5 inhibitor, and the drugs in this class were initially FDA-approved to treat erectile dysfunction (ED). He included information representative of the extensive history of overuse, diversion, and abuse, including by young people and in conjunction with illicit drug use. Both Revatio (sildenafil) and Adcirca (tadalafil) have an indication for treatment of pulmonary hypertension, but since they are the same drugs used to treat ED, they also carry the same potential for overuse, diversion, abuse, and illegal use. He then discussed the Committee's previous actions with regard to the PDE5 inhibitor class and Revatio, noting that in February 2006, the Committee unanimously recommended that NY Medicaid require prior authorization for Revatio under the CDRP. The Commissioner of Health approved the recommendation. Dr. Correia explained that adding Adcirca to the existing protocols established for Revatio, including the same procedures for checking sexual offender status and prior authorization, will ensure the drug is managed with the same considerations as Revatio. The clinical criteria questions for Revatio, developed by the P&T Committee, are directly applicable to Adcirca in their current form and can be used during the prior authorization process.

After further discussion and considering the information and concerns raised by interested parties and the membership, the Committee agreed that Adcirca (tadalafil) meets the criteria for inclusion into the CDRP and voted unanimously to recommend that it be included in the CDRP, implementing the same prior authorization process used for Revatio (sildenafil).

Inclusion of sodium oxybate (Xyrem) in the Clinical Drug Review Program (CDRP)

The Committee was asked to consider a proposal to include sodium oxybate (Xyrem) in the Clinical Drug Review Program. As presented, the drug would be included on the Medicaid list of reimbursable drugs and require prior authorization in order to evaluate and address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health and potential for overuse or misuse.

The Board was advised by State staff that the P&T Committee reviewed sodium oxybate (Xyrem) on November 14, 2005 at which time the Committee voted to recommend that Medicaid not reimburse for gamma-hydroxy butyric acid (GHB) under any name until a live interactive telephone prior authorization system is in place, which would provide more appropriate types of controls. The Commissioner of Health approved the recommendation. Now that the Medicaid program has a live telephone prior authorization system in place, the manufacturer of Xyrem has requested that it be placed on the list of reimbursable drugs for the Medicaid program.

Dr. Catanzaro presented the Committee with a review of sodium oxybate (Xyrem) with regard to the public health concern of the agent's abuse potential which may be associated with adverse events and death. She also noted the non-FDA approved indications for sodium oxybate, and the agent's potential for illicit use, and diversion. She described the distribution system via a centralized pharmacy and the Xyrem Success Program. She also provided information on utilization and prior authorization requirements from comparator state Medicaid programs.

Dr. Briscoe-Dwyer noted that sodium oxybate (Xyrem) was reviewed during the July 2, 2009 DUR Board Meeting. The DUR Board determined that sodium oxybate (Xyrem) met all three criteria for inclusion into the CDRP. The Board also had concerns about the lack of appropriate controls under the current system and the potential effect this would have on public health and safety if this agent was covered. The DUR Board recommended that Medicaid not reimburse for GHB under any name until more appropriate types of controls are in place to determine medical necessity. The current prescriber prevails provision does not allow for adequate control. The Board also recommended the State should be allowed to deny a prior authorization request unless a drug is determined to be medically necessary; however that discussion was tabled until the next meeting.

A Committee member expressed interest in knowing the indication for which sodium oxybate was being prescribed.

After further discussion and considering the information and concerns raised by interested parties and the membership, the Committee agreed that sodium oxybate (Xyrem) meets the criteria for inclusion into the CDRP and voted unanimously to recommend that it be included in the CDRP but only be approved for the indication of narcolepsy with cataplexy and denied for any other use.

Proposal to identify preferred drugs in the therapeutic class of Alzheimer's Agents

Dr. Rogler provided an overview of dementia and Alzheimer's disease. She discussed the pharmacological strategies for treatment including the acetylcholinesterase inhibitors (AChEIs) and the N-methyl-D-aspartate (NMDA) receptor antagonist. She discussed the agents in the therapeutic class with regard to indications, pharmacokinetics, drug interactions, dose, contraindications, warnings and precautions, metabolism, and pregnancy category. She noted a long term clinical trial comparing galantamine and donepezil, and she also discussed another clinical trial comparing combination therapy with memantine and donepezil versus donepezil and placebo.

Dr. Correia reiterated the two major mechanisms of action within this class. He noted the Oregon Drug Effectiveness Review Project has produced a comparative effectiveness and safety report on this drug class dated 2006, and the report has been reviewed annually, but not updated as there has not been any new clinical information found which would necessitate another complete update of the report. He indicated that effectiveness appears to be comparable overall for the drugs in this class, although comparative evidence is sometimes contradictory, and comparative trials may demonstrate better effect in some measures for one drug, and better effect for a different measure for another drug. Length of the studies and rate of dose titration may also contribute to questionable conclusions. He also noted evidence for addition of the NMDA inhibitor to a cholinesterase inhibitor is inconclusive.

He discussed comparative safety and effectiveness with regard to age, race, gender, and comorbid conditions such as Parkinson's Disease and vascular dementia, noting that differences in effectiveness of the drugs in special populations was inconclusive and conflicting, and often based on subgroup analysis. He noted that one drug in the class is indicated for Parkinson's Disease and also noted data did not support differences between the drugs based on disease severity. He concluded that current evidence does not predict which patient will respond better to which drug, or for which symptoms measured, no one drug in the class has demonstrated overall superiority, and it would be preferable to include as broad a selection of these products as possible.

A committee member asked about use of the Alzheimer's agents in non-Alzheimer's disease patients with cognitive deficits, and Dr. Correia and another Committee member concurred this is an area of ongoing research, but there is currently no evidence for this.

Proposal to identify preferred drugs in the therapeutic class of Sulfasalazine Derivatives

Dr. Rogler provided background information on ulcerative colitis including different treatment strategies based on the location of the disease in the colon and rectum. She presented the guidelines for treatment of ulcerative colitis noting differences in treatment for active disease versus remission maintenance. She discussed the pharmacological differences between the oral pro drugs and the oral delayed-release drugs, all of which ultimately release mesalamine or 5-aminosalicylic acid (5-ASA) into the colon for local anti-inflammatory action. She noted the product indications, contraindications, warnings, drug interactions and adverse effects, and discussed use in pregnancy and in the pediatric population.

Dr. Correia provided background information for the treatment of ulcerative colitis, noting that regardless of the route of administration (oral or rectal), the beneficial effect of the active drug 5-ASA, also known as mesalamine, is believed to have its therapeutic effect via topical exposure to the affected gastrointestinal area (intestinal lumen, rectum, or left colon). He noted the products in this class are categorized either by indication for active disease versus maintenance, or by mechanism used to deliver the active drug. He noted the pro-drugs require chemical conversion to their active form within the intestine, whereas delayed-release forms achieve this via dosage formulations. He reiterated dosing regimens vary from once a day to four times a day depending on drug and indication, and each dose still requires use of multiple tablets or capsules. He indicated balsalazide and sulfasalazine have an indication for use in pediatrics, and all the drugs in the class are Pregnancy Category B, except olsalazine, which is Category C. In conclusion, none of the agents demonstrates any overall superiority in safety or efficacy and it would be preferable to include as broad a selection of these products as possible.

Dr. Rogler noted the FDA recommended product label changes for the LABAs including discouraging use as first line agents for asthma, use for wheezing that is getting worse or occurs suddenly, and the recommendation that prescribed LABA therapy not be stopped without discussing with a healthcare professional.

Dr. Correia indicated no new information has been found to indicate any of these products demonstrates an overall clinical advantage in terms of either efficacy or safety.

Dr. Rogler discussed the method to prepare valacyclovir oral suspension, and noted that the drug has an indication for the treatment of chicken pox in immunocompetent pediatric patients 2 to ‹18 years of age.

Dr. Correia noted no new comparative evidence was found to differentiate effectiveness between the three drugs in this class, and all three in the oral form are effective. He indicated that while different drugs may have advantages for a specific use or patient population, no one drug has a significant advantage overall.

Dr. Rogler noted several product label changes for Sporanox (itraconazole) including use with calcium channel blockers and fentanyl, and also reported cases of hearing loss.

Dr. Correia indicated no new clinical evidence was found to change the previous assessment of the drugs in this class. He noted any of the three oral products are effective and may have advantages for particular infections or patient populations, with no one drug demonstrating overall advantages for all cases. The topical preparations are inferior and of questionable effectiveness in resolving onychomycosis compared to the oral agents.

A Committee member commented on drug interactions with terbinafine and itraconazole, respectively.

Dr. Rogler discussed the new Matrix formulation for Duragesic patch, and new strengths for Avinza (morphine sulfate ER). She also noted the products that are now required by the FDA to have a Risk Evaluation and Mitigation Strategy (REMS).

Dr. Correia indicated there was no new clinical evidence found since the last re-review of this class to indicate any of these drugs offers an overall advantage in terms of either efficacy or safety.

A Committee member asked for clarification regarding the pharmacokinetics of the extended release morphine products in the class.

Dr. Rogler noted several products with new dosing formulations, and several products that received indications for the treatment of growth failure in children born small for gestational age (SGA) and in children diagnosed with idiopathic short stature (ISS). She also noted the Updated 2008 Changes in Recombinant Human Growth Hormone Prescribing Information presented by the Lawson Wilkins Pediatric Endocrine Society. She discussed the guideline update with regard to the contraindications and warnings and precautions associated with somatropin, and discussed recent literature regarding additional dosing guidelines for adults.

Dr. Correia noted there is little comparative information between the products in this class because they are all the same drug, and they produce identical clinical effects. New comparative studies focus on reinforcing the concept of same effects of the drugs. Clinical contraindications and warnings should be considered to apply to all growth hormone products. He noted different manufacturers have pursued different FDA indications for their particular brand name products, and there is variety in package sizes and delivery devices as well. Dr. Correia reiterated from last year's review, the Endocrine Society has stated there are no observable differences in the results obtained from the different preparations as long as the appropriate regimen is followed, and there is no evidence that clinical outcomes differ among the various injection systems. Products with specific or rare indications may be addressed with prior authorization criteria if needed.

Dr. Rogler noted the expanded labeling for Copaxone (glatiramer acetate) which actually decreases the differences between the agents in the class.

Dr. Correia noted there is little new comparative information for this drug class. The new indication for glatiramer further decreases the differences between the products. He concluded that there is no evidence that any of these agents is better overall for all patients, and each may demonstrate favorable efficacy or tolerability for different patients.

Dr. Rogler discussed the expanded indication for PEG-Intron (peginterferon alfa-2b) and the approval for use of this agent in previously untreated patients three years of age or older. She also discussed the American Association for the Study of Liver Disease (AASLD) updated guidelines. She presented the results of the IDEAL Study which compared the safety and efficacy of the two standard regimens (peginterferon alfa-2a and peginterferon alfa-2b) and an experimental low dose peginterferon alfa-2b regimen, and noted that the primary end points were not met.

Dr. Correia reiterated peg-interferon alfa-2b acquired new and expanded indications in the labeling, including a pediatric indication. He noted in July of 2009 new safety information was added to the labeling of peg-interferon alfa-2b in the clinical trials and postmarketing experience sections regarding reported adverse effects, including clinical trial information that decreases in hemoglobin, neutrophils, and platelets may require dose reduction or permanent discontinuation from therapy. He spoke about the results of the IDEAL study and noted this was a complex study with varying doses of the interferons and ribavirin. The findings of the study reinforce previous evidence, as the rates of sustained virological response and tolerability did not differ between the interferon treatments. He also noted that increased ribavirin exposure during the treatment phase was associated with an increased likelihood of sustained virological response in all groups. He concluded that overall, there is still no published data to demonstrate either of these products is superior overall, although each may demonstrate preferential characteristics within specific sub-populations.

Dr. Rogler noted a new indication for ProAir HFA (albuterol) and clarified the expiration dating for the albuterol HFA products in the class with regard to storage in or out of foil wrapping, as applicable.

Dr. Correia noted good quality comparative new evidence for the inhaled short acting beta agonists is lacking, with nothing significantly new since the last review, and there is inadequate evidence to demonstrate significant overall clinical superiority to justify preferential availability of any one product.

Dr. Rogler discussed two new clinical trials for inhaled anticholinergics. The UPLIFT trial, which was a four year trial of tiotropium in chronic obstructive pulmonary disease, and a systematic review and meta-analysis titled: Inhaled Anticholinergics and Risk of Major Adverse Cardiovascular Events in Patients with Chronic Obstructive Pulmonary Disease. She also noted that the FDA has not provided a final determination regarding an FDA Early Communication dated March 18, 2008 pertaining to a possible increased risk of stroke in patients on tiotropium therapy.

Dr. Correia indicated there is new information related to possible safety concerns for these drugs but there may be an overall concern for the cardiovascular impact of the entire drug class. He noted the FDA issued an early communication in 2008 that patients in the inhaled tiotropium group experienced a "possible increased risk of stroke" based on a pooled analysis with the risk reported compared to placebo. In September 2008, a systematic review and meta-analysis was published in the Journal of the American Medical Association which evaluated both of the inhaled anticholinergics in COPD, and the review found increased risk for both tiotropium and ipratropium. The conclusion of this review was that inhaled anticholinergics are associated with a significantly increased risk of cardiovascular death, MI, or stroke among patients with COPD. Dr. Correia concluded that different products may be more appropriate at different points of disease process or progression, but there has been no new evidence since the last review to support overall clinical superiority or increased risk differentially between these products.

A Committee member commented on the complexity and unrelenting nature of COPD, which is often further complicated with smoking, and indicated it can be difficult to draw conclusions with regard to the drugs used for treatment of this disease.

Dr. Rogler discussed the FDA Guidance on Evaluation of Cardiovascular (CV) Risk of Antidiabetic Therapies which requires that manufacturers of new antidiabetic agents provide evidence that those agents will not increase the risk of certain CV events. She also discussed the Medical Management of Hyperglycemia in Type 2 Diabetes: A Consensus Algorithm for the Initiation and Adjustment of Therapy: A consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes dated January 2009. The algorithm notes glycemic goals, common adverse effects, and a consensus among group members advising against the use of rosiglitazone.

Dr. Correia noted that controversy remains about the potential adverse effect profiles of pioglitazone, rosiglitazone, or the TZD class in general. As he discussed in the last re-review, comparative or specific information pertaining to these adverse effects includes an inconclusive meta-analysis and a prospective study which didn't meet its primary endpoints. He discussed the RECORD trial and the BARI 2D trial and noted neither provided the evidence needed to answer these important questions regarding cardiovascular risk. Dr. Correia reiterated the consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. He concluded there has been no new comparative information to resolve the question of cardiovascular risk, there is no comparative evidence which clearly demonstrates an advantage of either of these products overall, and the current FDA determination remains that the available data concerning safety is inconclusive.

E. Executive Session:

The Committee recessed the public session at 12:30 PM to go into executive session for review of financial information relating to the recommendation of preferred drugs in the following classes: Alzheimer's Agents, Sulfasalazine Derivatives and Growth Hormones. No official action was taken in the executive session. The executive session was recessed at 2:30 PM.

The Committee recessed the public session at 3:20 PM to go into executive session for review of financial information relating to the recommendation of preferred drugs in the following classes: Inhaled Beta-2 Adrenergic Agents - Long Acting and Short Acting, Anti-Virals, Anti-Fungals, Long Acting Narcotics, Multiple Sclerosis Agents, Pegylated Interferons, Inhaled Anticholinergics and Thiazolidinediones. The executive session was recessed at 3:40 PM.

F. Recommendations of the Pharmacy and Therapeutics Committee:

The following recommendations developed by the P&T Committee are to be submitted to the Commissioner of Health for final determination.

Description of Recommendations

Commissioner's Final Determination

Proposal: Inclusion of the Growth Hormone therapeutic class in the Clinical Drug Review Program

A. The Committee unanimously recommended that Medicaid include the Growth Hormone therapeutic class in the Clinical Drug Review Program and prior authorization be required for patients 21 years of age or older.

B. The Committee unanimously recommended the following questions be asked in the prior authorization process of Growth Hormones for patients 21 years of age and older:

1) Has the patient been diagnosed with adult or childhood onset Growth Hormone Deficiency or Short Bowel Syndrome?

3) For patients being prescribed Growth Hormone for short bowel syndrome, is the patient on specialized nutritional support?

Approved as Recommended

Proposal: Inclusion of Adcirca (tadalafil) in the Clinical Drug Review Program

A. The Committee unanimously recommended that Medicaid include Adcirca (tadalafil) in the Clinical Drug Review Program.

B. The Committee unanimously recommended the following questions be asked in the prior authorization process of Adcirca (tadalafil):

1) Are you the practitioner on record primarily responsible for the management of the condition requiring the use of Adcirca for this patient?

2) Are you currently board certified in Pulmonary or Cardiovascular disease or is there documentation in the patient's medical record of an evaluation by a physician, board certified in Pulmonary or Cardiovascular disease?

3) What is the diagnosis documented in the patient's chart that requires treatment with Adcirca?

5) What NYHA/WHO classification describes the patient's current functional status?

6) Before prescribing this drug, have you inquired about regular or intermittent therapy with nitrates or drugs containing nitrates within the past 180 days and completed counseling for this patient including strong warning against the use of any drugs containing nitrates in conjunction with Adcirca?

7) Is the patient currently using an oral erectile dysfunction medication?

8) Have you evaluated for retinitis pigmentosa and completed counseling on the risk of ocular disturbances, non-arteric anterior ischemic optic neuropathy (NAION) and potential for blindness?

Approved as Recommended

Proposal: Inclusion of Xyrem (sodium oxybate) in the Clinical Drug Review Program

A. The Committee unanimously recommended that Medicaid include Xyrem (sodium oxybate) in the Clinical Drug Review Program. The Committee also recommended that based on the evidence presented, Xyrem be only used for the indication of narcolepsy with cataplexy with prior authorization and should be denied for any other indication.

B. The Committee unanimously recommended the following questions be asked in the prior authorization process of Xyrem (sodium oxybate):

1) Does the patient have a diagnosis of narcolepsy with cataplexy?

2) Is the prescriber a board certified sleep specialist, pulmonologist, neurologist or psychiatrist?

3) Is the patient currently using a sedative-hypnotic, other CNS depressant or alcohol?

4) Is the total daily dose of sodium oxybate 9 grams per day or less?

5) Has the patient been evaluated by the prescriber within the past 3 months for narcolepsy with cataplexy?

The Committee also recommended that prescriptions be limited to a maximum of one month supply with two refills.

The Commissioner determined that Xyrem (sodium oxybate) be included in the Clinical Drug Review Program and prior authorization be required for coverage. The following questions will be asked in the prior authorization process:

Is the prescriber a board certified sleep specialist, pulmonologist, neurologist or psychiatrist?

Does the patient have a diagnosis of cataplexy or excessive daytime sleepiness due to narcolepsy?

Has the patient been evaluated by the prescriber within the past 3 months for the condition being treated?

Is the patient currently using a sedative-hypnotic, other CNS depressant, or alcohol?

Has the patient attempted to use another drug accepted for the treatment of this condition and experienced therapeutic failure?

The Commissioner further determined that prior authorization requests identified as not medically appropriate or when fraud/abuse/ misuse is suspected, will be referred to the Office of the Medicaid Inspector General for further investigation

Prior authorization requests will be denied in cases where there is substantial evidence of fraud or abuse.

Proposal: Identification of preferred drugs in the category of Alzheimer's Agents

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

After the Commissioner considered new financial information which became available subsequent to the Pharmacy and Therapeutics Committee meeting, the final determination for preferred and non-preferred drugs is as follows:

B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.

Approved as Recommended

Proposal: Identification of preferred drugs in the category of Pegylated Interferons

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

B. The Committee unanimously recommended the standard clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug.

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended

The Meeting adjourned at 3:45 PM

Meeting Summary Posted 10/5/09

G. Final Determinations

The Commissioner has determined that the Medicaid program will require prior authorization under the Clinical Drug Review Program (CDRP) for the Growth Hormone therapeutic class, Adcirca (tadalafil) and Xyrem (sodium oxybate) as detailed in Section F above.

The impact of this final determination is as follows:

State Public Health Population:

Products requiring prior authorization under the CDRP will or continue to be covered by the Medicaid program. The prior authorization requirement will have a minimal effect on Medicaid enrollees, and will ensure the product is being used in a medically appropriate manner.

Program Providers:

There will be a minimal impact on prescribers and pharmacies as they are familiar with the prior authorization process. The prior authorization process is simple to use and available twenty-four hours a day, seven days a week.

Prescribers will need to initiate the prior authorization process and will be asked for clinical information to support appropriate use of the product when ordering these medications. Pharmacies will need to complete the prior authorization process prior to submitting the claim.

State Health Program:

Prior authorization through the CDRP will reinforce appropriate use and will also provide an additional means to detect and deter overuse.

The fiscal impact will depend on changes in utilization associated with assuring the appropriate use of the product. For those products currently covered, expenditures will be expected to decrease subsequent to the implementation of the prior authorization requirement.

The Commissioner has determined that the Medicaid program will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs in each of the drug classes as listed in
Section F.

Preferred Drugs will not require prior authorization

The impact of this final determination is as follows:

State Public Health Population:

Minimal effect on Medicaid enrollees, as a large majority of enrollees currently utilize preferred products.

Non-preferred products remain available when prior authorized.

Program Providers:

No impact on prescribers or pharmacies when utilizing preferred products. Prescribers, or their agents, will need to initiate the prior authorization process when ordering non-preferred products.
Pharmacies will need to complete the prior authorization process for non-preferred products.

State Health Program:

Annual gross savings associated with these therapeutic classes under the PDP are estimated at $28M. The savings are achieved through changes in utilization to equally effective and less expensive drugs including the receipt of supplemental rebates from pharmaceutical manufacturers.